Analytical Method Development & Validation
Lead development of analytical methods for complex peptide molecules(HPLC/UPLC, LCMS, GCHS, Amino Acid Analysis).
Implement Analytical QbD principles, including risk assessment (FMEA) and method lifecycle management.
Perform and/or review method validation protocols, reports, and transfer packages.
Define impurity characterization strategies (epimerization, oxidation, deamidation, peptide variants).

Tech Transfer & Manufacturing Support
Lead analytical readiness for plant transfers; ensure smooth movement of methods to QC.
Support PPQ batches, change control activities and analytical troubleshooting at plant.

Regulatory & Compliance
Ensure strict GLP, GMP, and dataintegrity (ALCOA+) compliance across all analytical activities.
Represent the analytical function during customer audits, regulatory interactions, and technical meetings.

Customer / Stakeholder Interface




Act as the primary technical SME for analytical queries from global customers.
Lead technical discussions, responses to client questions, and CMCanalytical sections when needed.
Ensure customer expectations for timelines, reporting, and quality are consistently met.

Instrumentation & Asset Management
Oversee calibration, preventive maintenance, and instrument qualification schedules
Develop a multiyear instrumentation roadmap (LCMS upgrades, detector strategy, AAs analyzers).

Technical Competencies
Expert in peptide analytical method development and validation (HPLC/UPLC, LCMS, GCHS).
Understanding of peptide chemistry, degradation pathways, and impurity mechanisms.
Robust knowledge of ICH guidelines, regulatory expectations, and global filing requirements.
Handson experience with troubleshooting instrumentation and analytical problems.

📌 Senior Principal Scientist Analytical Development Peptide Maharashtra
🏢 Piramal Pharma
📍 Maharashtra